Kornimate/medical-research-clean huggingface dataset:
know-ckd cohort, phase ii study

Conditions: Chronic Kidney Diseases

Summary: the goals of know-ckd (korean cohort study for outcome in patients with chronic kidney disease) study are 1) to establish a ckd cohort representing korean ckd population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence. know-ckd phase i has enrolled 2,238 patients and these patients were divided into four major subgroups depending on the specific causes of ckd : glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, and polycystic kidney disease. in progress, renal progression, complications, and cardiovascular disease of these patients are followed up now. since there was a lack of information related to patients' lifestyle, it is necessary to conduct various studies that can be applied to actual clinical status through evaluation of nutrition, cognitive functions, and lifestyles of patients with ckd in south korea. in addition, researches for high risk patients including diabetic nephropathy, advanced ckd and elderly patients are needed. thus, know-ckd phase ii will enroll the ckd subjects at a more advanced-stage, and older patients than know-ckd phase i subjects. know-ckd phase ii investigator group comprises nephrologists, epidemiologists and statisticians from multi-centers in south korea. know-ckd phase ii will enroll 1,500 individuals with estimated glomerular filtration rate between 20 and 60ml/min/1.73m2 (ckd-epi\[cr\] equation) between 2019 and 2021 and follow them until 2016 (for 5\~7 years). unlike phase i, patients diagnosed with glomerulonephritis and adpkd will be excluded in phase ii.

at enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, and anemia. nutritional evaluation through skin fold, hand grip test, bioelectrical impedence analysis, and 7-point subjective global assessment (sga), food frequency questionnaire (ffq) will be conducted in a subgroup of patients. information on the medical history, health questionnaires, qol, k-moca will also be collected. web-based case-report forms (crf) will be used for the systematic management of the patient data.

Eligibility criteria:
inclusion criteria: * age 45-79 years * estimated glomerular filtration rate 20-60ml/min/1.73m2 based on ckd-epi(cr) equation * non-dialysis dependent (ndd) exclusion criteria: * autosomal dominant polycystic kidney disease * unable or unwilling to give consent * previously received chronic dialysis * previous any organ transplant * patients who diagnosed heart failure with nyha class 3 or 4 * known liver cirrhosis (child-pugh class 2 or 3) * pregnant women * single kidney due to trauma or donation * patients who received immunosuppressive agent within the past 1 year * patients who diagnosed with glomerulonephritis through kidney biopsy

Keywords: renal progression mortality complications risk factors
anesthesia and post-operative mortality after proximal femur fractures

Conditions: Hip Fractures

Summary: this study evaluates the effect of anesthesia on mortality after surgical repair of proximal femur fracture. patients will receive either a subarachnoid block or a combination of peripheral nerve blocks and light general anesthesia (pnb/ga). the investigators hypothesis is that a combination of peripheral nerve blocks with an opioid free light anesthesia may have more favourable outcomes. both groups will be followed up for assessment of post-operative morbidity and mortality.

proximal femur fracture is one of the most common causes of admission in emergency departments. mortality is high among these patients and is reported to range from 10% at 30 days, up to 32% at one-year post-operative. several strategies to reduce mortality have been used, but mortality rate has plateaued since 1998. attempts to show benefit from regional or general anesthesia have shown inconsistent results. new techniques with peripheral nerve blocks have been used, but their effect on mortality when used as major anesthesia component have not been studied. the investigators hypothesise that smaller physiologic impact of peripheral nerve blocks associated to light general anesthesia may improve survival rates and reduce short term delirium after proximal femur fracture surgery. recovery of quality of life will also be assessed. patients will be randomized into two groups, being allocated for a subarachnoid anesthesia or a combination of peripheral nerve blocks and light general anesthesia. patients will be followed up for short-term post-operative complications such as incidence of delirium, recovery of quality of life and survival up to one year.

Eligibility criteria:
inclusion criteria: * patients admitted wiht a diagnosis of proximal femur fracture (icd-9 codes 820.0 to 820.9) and submitted to surgical internal fixation of femur or hip prosthesis (icd-9 codes 7935, 8151 and 8152) exclusion criteria: * multiple fractures; polytrauma, active malignancy, asa(american society of anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, contra-indication to general or regional anesthesia

Keywords: hip fracture regional anesthesia peripheral nerve blocks post-operative mortality cognitive dysfunction quality of life
infrared photomodulation therapy for seasonal affective disorder

Conditions: Seasonal Affective Disorder

Summary: during winter months in northern latitudes use of joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. participants will also submit withings and oura activity and sleep data.


Eligibility criteria:
inclusion criteria: * history of mental health issues including clinical depression * us based * reasonably active individuals (self report run/gym 3x per week or more) exclusion criteria: * average daily high temperature in zipcode above 60 degrees through end of march
efficacy of iontophoresis in treating lateral epicondylitis patients

Conditions: Lateral Epicondylitis

Summary: this study is conducted to evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.

this study is conducted to evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis. background: lateral epicondylitis (le) (tennis elbow) is a tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use (mostly of the extensor carpi radialis brevis), forced extension or direct trauma in the epicondyle . le has an approximate rate of 40% and a prevalence of 1-3% of the general population . it mostly affects people 40 years and older. some studies indicate that men and women are equally affected; others report a higher percentage of affected women . hypotheses it will be hypothesized that: there will be no statistically significant effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis. definition of terms lateral epicondylitis: pain and tenderness over the lateral epicondyle of the humerus, and pain on resisted dorsiflexion of the wrist, middle finger, or both . iontophoresis: is a technique used to enhance transdermal penetration of substances through the application of electric current . research question: this study will be conducted to answer the following question: what is the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis?

Eligibility criteria:
inclusion criteria: * • their age will be ranged between 20-50 years with both gender * pain on the lateral side of the elbow for at least 4 weeks * tenderness over the lateral epicondyle * at least two positive provocative tests: mill test and thomson test exclusion criteria: * • history of injection, surgery, physical therapy in the elbow area in the last 3 months * previous elbow surgery * history of radius/ulna fracture * history of cervical and shoulder problems * having bilateral symptoms * concomitant medial epicondylitis * malignancy * pregnancy * systemic rheumatologic disease or systemic infection * inserted cardiac pacemaker * presence of coagulation disorders * cognitive dysfunction

Keywords: iontophoresis
intra-operative assessment of the praetorian score during s-icd implantation

Conditions: Sudden Cardiac Death

Summary: the praetorian score predicts defibrillation test success in subcutaneous icd implantation but can only be calculated after the procedure. this pilot study aims to evaluate the feasibility of determining the praetorian score intraoperatively. lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. ten consecutive patients scheduled for s-icd implantation will be enrolled. the study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest x-ray on day one.

the praetorian score is an established tool to predict defibrillation test success in subcutaneous icd implantation but can only be calculated post-procedure using chest x-ray. this pilot study aims to evaluate the feasibility of determining the praetorian score intra-operatively. this pilot study will assess whether lead-to-sternum distance and generator position can be accurately measured during the implantation procedure by manual measurements with non-fluoroscopic means. this would potentially allow risk stratification before intra-operative defibrillation testing. ten consecutive patients scheduled for s-icd implantation will be enrolled. the study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest x-ray on day one. if successful, this approach could improve implantation safety by identifying high-risk patients before defibrillation testing.

Eligibility criteria:
inclusion criteria: * consecutive patients presenting for s-icd implantation at our institution exclusion criteria: * patients unable to consent. * pregnancy

Keywords: s-icd defibrillator
development a predictive nomogram for primary ovarian insufficiency

Conditions: Primary Ovarian Insufficiency

Summary: the purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.

many researches show primary ovarian insufficiency(poi) etiology is related with gene,immunization,iatrogenic, infection factors and social factors etc. in fact, approximate 70-90% poi have no definite cause, so a lot of patients don't know what will happen when they in occult stage of poi. in this research, researchers will investigate all possible factors in poi patients and normal women and select the valuable risk factor by integrated by statistical method to establish the reasonable predictive model. this study consists two stages.the fist stage is the model establishment, the second stage is the certificate and evaluate the model.

Eligibility criteria:
inclusion criteria: * age18--42 * definite spontaneous last menstrual period * informed consent for participating this research and could answer the questionnaires faithfully. exclusion criteria: * congenital gonadal dysgenesis and non organic diseases lead to menstrual disorders. * endocrine diseases such polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, low gonadotropin menstrual disorders and hyperthyreosis * reproductive toxicity of drugs used * release of chemotherapeutic drugs * accept sex hormone medicine in recent 3 months * pregnant and lactating women * with serious heart, liver, kidney and other diseases * with severe psychiatric disorders

Keywords: primary ovarian insufficiency nomogram
systematic description of the post emr defect

Conditions: Delayed Bleeding Post EMR; Large Laterally Spreading Lesion in the Colon; Endoscopic Mucosal Resection

Summary: to date there are no available data on the utility of the endoscopic mucosal resection (emr) defect in stratifying the risk of immediate or delayed adverse outcomes, particularly clinically significant post emr bleeding (cspeb). the investigators aimed to analyse the data to determine if any of these emr defect features allow us to estimate the risk of cspeb. this will help endoscopists to identify defects with a high risk of adverse outcomes and may translate into improved patient outcomes.

cspeb is the most frequent serious complication after wide-field emr of laterally spreading lesions ≥ 20mm (lsls). there is no proven therapy for cspeb and it remains a significant drawback of emr. visible vessels within the post emr defect (ped) present themselves as logical targets for prophylactic treatment to prevent cspeb. however, the clinical significance of these vessels is largely unknown. in the majority of studies risk factors identified for cspeb include right colon location, lesion size and aspirin use. the investigators aimed to systematically describe and evaluate the clinical significance of the various endoscopic features of the post emr defect ped including visible vessels. a prospective study of lsls ≥ 20mm referred for emr at a single tertiary referral center will be performed. data collection includes patient, procedural and lesion characteristics. in all cases a systematic description of the ped is undertaken. the data of particular interest to this study includes: use of blood thinners, ped features including size, number and herniation of visible vessels, submucosal haemorrhage, fibrosis, fat and exposed muscle and the rate of cspeb.these features were analysed for significant association with cspeb. cspeb was defined as any bleeding occurring after the completion of the procedure necessitating emergency department presentation, hospitalization or reintervention. cspeb was compared to features of the ped to detect significant associations, using chi2 or fisher's exact tests. significant univariate variables will be taken forward for binomial logistic regression modelling.

Eligibility criteria:
inclusion criteria: * all patients referred for emr of a lsl 20mm or larger * signed the informed consent exclusion criteria: * clips used during the emr procedure to close the defect, totally or partially * inadequate images to adequately assess the defect * use of blood thinners which have not been ceased according to the current guidelines for emr
effects of an integrative treatment model to reduce anxiety and depression in minor mental health problems and medically unexplained symptoms

Conditions: Depression; Anxiety; Irritable Bowel Syndrome; Fibromyalgia

Summary: minor mental health problems, mmhp, like mild depression and anxiety, and medically unexplained symptoms, mus, symptoms with no known underlying organic disease, are strongly associated to each other. mmhp and mus have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. the investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with mmhp or mus in primary care. the investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. primary endpoints were anxiety and depression (assessed with the hospital anxiety and depression scale), health-related quality of life (sf-36) and coping with stress, sense of coherence (soc) during the eight weeks of treatment interventions. statistical power was calculated based on an expected 50% reduction in had anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. a total of 120 (40/arm) were needed to achieve a power of 83% at p \<0.05. treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. nonparametric analyses were carried out to test differences between independent samples (kruskal-wallis and mann-whitney u) and related samples (wilcoxon).


Eligibility criteria:
inclusion criteria: * one or more symptoms of emotional and physical fatigue * worry * anxiety * depression * sleep disturbances or somatic pain exclusion criteria: * 100% sick leave \> 2,5 years * pregnancy * cancer * personality disorders * substance use disorders or prescribed sedative drugs

Keywords: integrative medicine acupuncture minor mental health problems medically unexplained symptoms minor mental health problems (e.g. minor depression and anxiety) and medically unexplained symptoms (e.g. ibs, fibromyalgia, etc)
multi-center comparative trial of the asr™-xl acetabular cup system vs. the pinnacle™ metal- on- metal total hip system

Conditions: Non-inflammatory Degenerative Joint Disease

Summary: the primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the asr™-xl acetabular cup system compared to the pinnacle™ acetabular cup with a 28mm or 36mm ultamet™ metal insert.

the purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. the treatment group/device for this study is the asr™-xl acetabular cup system, and the control group/device is the pinnacle™ cup system w/ the 28mm or 36mm ultamet™ metal liner. the study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study subjects.

Eligibility criteria:
inclusion criteria: * subject is able to or capable of providing consent to participate in the clinical investigation. * subject is between the ages of 20-75 years, inclusive. * subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (nidjd). * subject has sufficient bone stock for the hip replacement device. * subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device. exclusion criteria: * subject, in the opinion of the investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation. * subject with a known allergy to metal (e.g. jewelry). * subject has inflammatory arthritis (e.g. rheumatoid arthritis). * subject has active or recent joint sepsis. * subject with marked atrophy or deformity in the upper femur. * subject with a neuromuscular disease where the loss of musculature would affect functional outcome. * subject, in the opinion of the clinical investigator, has a history of chronic renal insufficiency (e.g. dialysis). * subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery. * subject with known, active metastatic or neoplastic disease. * subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser. * subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.

Keywords: hip arthroplasty acetabular cup replacement acetabulum arthroplasty
the efficacy of kidnet in the treatment of traumatized refugee children in germany

Conditions: PTSD

Summary: the purpose of the study is to assess the effectiveness of kidnet in treating traumatized refugee children in germany


Eligibility criteria:
inclusion criteria: * refugee children * age range: 7-16 * ptsd-diagnosis exclusion criteria: * none

Keywords: ptsd children trauma-focused treatment kidnet narrative exposure therapy for children
an extension study for participants who have completed the treatment period of a qualifying parent study

Conditions: Dermatomyositis

Summary: the purpose of this research study is to evaluate the long-term safety, and tolerability of pf-06823859 study drug in adult participants with dermatomyositis (dm) from a qualifying study.


Eligibility criteria:
inclusion criteria: * participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (dm), that have completed the treatment period of a qualifying study. * capable of giving signed informed consent. * participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. exclusion criteria: * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study * participants who met discontinuation criteria at any point during the participating qualifying studies. * participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern or the participant has met safety monitoring criteria in the qualifying study that has not resolved.
ctc detection rate in scchn with a in vivo device

Conditions: Circulating Tumor Cell; Squamous Cell Carcinoma of the Head and Neck

Summary: detection rate and isolation yield of ctc is low in squamous cell carcinoma of head and neck (scchn) with in vitro approaches rely on limited sample volumes. in this study, we applied a new method, the cellcollector, which could capture ctc in vivo from peripheral blood.


Eligibility criteria:
inclusion criteria: * scchn confirmed with clinical examination * have agreed to undergo ctc analysis in vivo; * ecog：0-2 exclusion criteria: * the other cancer types
the natural history and prognostic factors of compensated cirrhosis.

Conditions: Compensated Cirrhosis

Summary: study design and methodology * study population:compensated cirrhosis * study design: an ambi prospective cohort study * study period: 2 years * sample size: retrospective- all patients from jan 2010 to mar 2017 prospective- assuming the incidence of clinical decompensation is 5%/year.with alpha of 5%, power 80% we need to enroll 138 cases. further assuming 20% drop out 166 cases will be enrolled. * intervention: this is an observational study. no intervention will be given. monitoring and assessment: all the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years 2. compensated cirrhosis 3. biopsy proven cirrhosis or lsm \> 12.5 kpa. exclusion criteria: 1. any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage). 2. pregnant women 3. hepatocellular carcinoma 4. known case of severe cardiopulmonary disease 5. known case of severe hepato pulmonary syndrome
effectiveness of the precision spinal cord stimulator system at sub-perception amplitude

Conditions: Chronic Pain

Summary: to demonstrate sustained clinically significant pain relief in patients with chronic pain when using the boston scientific precision spinal cord stimulator (scs) system at sub-perception amplitude

to demonstrate sustained clinically significant pain relief in patients when using the boston scientific precision spinal cord stimulator (scs) system at sub-perception amplitude

Eligibility criteria:
key inclusion criteria: 1. complaint of chronic pain of the trunk and/or limbs 2. willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in english 3. subject signed a valid, institutional review board (irb)-approved informed consent form (icf) provided in english key exclusion criteria: 1. meets any contraindication in the precision scs system per locally applicable directions for use (dfu) 2. any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes